MAUDE Adverse Event Report: PORTLESS TUBING; TUBING, FLUID DELIVERY

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/09/2018

Event Type  Injury  

Event Description

Coring occurred with portless tubing after being spiked.

• Brand Name: PORTLESS TUBING
• Type of Device: TUBING, FLUID DELIVERY
• MDR Report Key: 7511837
• MDR Text Key: 108292942
• Report Number: MW5077204
• Device Sequence Number: 1
• Product Code: FPK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other